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Physiological Effects of Different Preoxygenation Strategies (PREOXY II)

2026년 5월 6일 업데이트: Simon Rauch, Institute of Mountain Emergency Medicine

Physiological Effects of Different Preoxygenation Strategies in Adults and Children: A Comparative Study of NRM and BVM With and Without PEEP

The goal of this clinical trial is to evaluate the performance and physiological effects of different preoxygenation devices in healthy adult and pediatric volunteers (children aged 5-12 years). The study aims to determine how these devices influence oxygen delivery, airway pressure, and cardiopulmonary physiology during preoxygenation.

The main questions it aims to answer are:

  • What fraction of inspired oxygen (FiO₂) is delivered by non-rebreather masks (NRM) compared to bag-valve masks (BVM) with and without positive end-expiratory pressure (PEEP)?
  • How do these devices differ in terms of generated PEEP, inspiratory effort, and their effects on lung ventilation and cardiac function?

Researchers will compare NRM, BVM without PEEP, and BVM with PEEP (each with or without supplemental oxygen via nasal cannula) to evaluate differences in oxygenation and physiological effects.

Participants will:

  • Complete multiple 3-minute preoxygenation sessions using each device in randomized order
  • Breathe spontaneously through each device, with or without additional oxygen via nasal cannula
  • Undergo non-invasive monitoring of oxygen concentration (FiO₂), respiratory parameters, airway pressures, and ultrasound assessment of the lungs, diaphragm, and heart
  • Perform a brief breath-holding maneuver to assess airway pressure generation

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

Hypoxemia is a frequent and potentially life-threatening complication during advanced airway management, associated with adverse outcomes such as hypoxic brain injury, cardiovascular collapse, and death. Effective preoxygenation is essential to increase oxygen reserves and prolong safe apnea time during intubation. Although several devices are routinely used for preoxygenation, including non-rebreather masks (NRM) and bag-valve masks (BVM) with or without positive end-expiratory pressure (PEEP), important uncertainties remain regarding their actual performance and physiological effects.

Current evidence suggests that techniques providing PEEP may improve oxygenation by increasing functional residual capacity, enhancing ventilation of dependent lung regions, and reducing ventilation-perfusion mismatch. However, the relative contribution of FiO₂ delivery versus PEEP, as well as the physiological effects on respiratory mechanics and cardiovascular function, are not fully understood. In addition, it remains unclear whether BVM devices without a dedicated PEEP valve can generate measurable PEEP, and whether patients can generate sufficient inspiratory effort to effectively operate BVM valves without assisted ventilation. Data in pediatric populations are particularly limited.

This randomized crossover study is designed to systematically evaluate the performance of commonly used preoxygenation devices under controlled conditions in healthy adult and pediatric volunteers. By comparing NRM, BVM without PEEP, and BVM with PEEP-with and without supplemental oxygen via nasal cannula-the study aims to characterize differences in oxygen delivery, airway pressure generation, inspiratory effort, and their physiological impact.

The study will focus on key physiological domains, including oxygenation (FiO₂), respiratory mechanics (tidal volume, airway pressures, and diaphragm activity), lung aeration (with particular attention to dependent lung regions), and cardiovascular responses (including right ventricular dimensions and function). Measurements will be obtained using non-invasive monitoring techniques, including gas analysis and ultrasound.

The crossover design allows within-subject comparisons across all study conditions, minimizing inter-individual variability and enabling precise assessment of device-related effects. The findings of this study are expected to improve understanding of the mechanisms and physiological consequences of preoxygenation strategies, with potential implications for optimizing airway management practices in both adult and pediatric populations.

연구 유형

중재적

등록 (추정된)

30

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 이탈리아
    • BZ
      • Bolzano, BZ, 이탈리아, 39100
        • 모병
        • Eurac research, Institute of mountain emergency medicine
        • 연락하다:
        • 연락하다:
        • 부수사관:
          • Ruth Martintoni
        • 수석 연구원:
          • Simon Rauch, MD, PhD
        • 수석 연구원:
          • Giulia Roveri, MD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

설명

Inclusion Criteria:

  • Adults with an American Society of Anesthesiologists (ASA) physical status score ≤ 2
  • Children aged 5 to 12 years with an ASA physical status score ≤ 2
  • Ability (or legal guardian ability) to provide written informed consent

Exclusion Criteria:

  • Children aged < 5 years or 13 to 18 years
  • ASA physical status score > 2
  • Body mass index (BMI) ≥ 30 kg/m²
  • Known airway pathology or anatomical abnormality that could affect mask fit, ventilation, or oxygenation
  • Presence of an active airway infection at the time of the study
  • Pregnancy
  • Refusal or inability to provide informed consent

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Nasal Cannula (NC)
Preoxygenation over 3 minutes with a nasal cannula (NC) with supplemental oxygen delivered at 15 L/min, during spontaneous breathing.
장치: Nasal cannula (NC)
Preoxygenation performed using a nasal cannula delivering supplemental oxygen at a flow rate of 15 L/min, without the use of an additional mask or ventilation device, during spontaneous breathing.
실험적: Non-rebreather facemask (NRM)
Preoxygenation over 3 minutes with a Non-rebreather facemask (NRM) with supplemental oxygen delivered at 15 L/min, during spontaneous breathing.
장치: Non-rebreather mask (NRM)
Preoxygenation performed using a non-rebreather mask with reservoir, delivering oxygen at a flow rate of 15 L/min. The mask is fitted to ensure an optimal seal, and participants breathe spontaneously without assisted ventilation.
실험적: Non-rebreather facemask (NRM) plus Nasal Cannula (NC)
Preoxygenation for 3 minutes using a non-rebreather mask (NRM) combined with a nasal cannula delivering supplemental oxygen at 15 L/min for each device, during spontaneous breathing.
장치: Non-rebreather mask (NRM) plus Nasal cannula (NC)
Preoxygenation performed using a non-rebreather mask with reservoir, delivering oxygen at a flow rate of 15 L/min, combined with a nasal cannula delivering supplemental oxygen at 15 L/min. The mask is fitted to ensure an optimal seal, and participants breathe spontaneously without assisted ventilation.
실험적: Bag valve mask (BVM)
Preoxygenation for 3 minutes using a bag-valve-mask (BVM) with supplemental oxygen delivered at 15 L/min, during spontaneous breathing.
장치: Bag-valve mask (BVM) without PEEP
Preoxygenation performed using a bag-valve mask without a PEEP valve, delivering oxygen at a flow rate of 15 L/min. The mask is held with a two-handed technique to ensure an airtight seal, without providing assisted ventilation, allowing spontaneous breathing.
실험적: Bag valve mask (BVM) plus Nasal cannula (NC)
Preoxygenation for 3 minutes using a bag -valve-mask (BVM) combined with a nasal cannula delivering supplemental oxygen at 15 L/min for each device, during spontaneous breathing.
장치: Bag-valve mask (BVM) without PEEP + nasal cannula (NC)
Preoxygenation performed using a bag-valve mask without a PEEP valve, delivering oxygen at a flow rate of 15 L/min, combined with a nasal cannula delivering supplemental oxygen at 15 L/min. The mask is held with a two-handed technique to ensure an airtight seal, without providing assisted ventilation, allowing spontaneous breathing.
실험적: Bag valve mask (BVM) plus PEEP
Preoxygenation for 3 minutes using a bag-valve mask (BVM) with positive end-expiratory pressure (PEEP) set at 10 cmH₂O and supplemental oxygen delivered at 15 L/min, during spontaneous breathing.
장치: Bag-valve mask (BVM) with PEEP
Preoxygenation performed using a bag-valve mask equipped with a PEEP valve set at 10 cmH₂O, delivering oxygen at a flow rate of 15 L/min. The mask is held with a two-handed technique to ensure an airtight seal, without assisted ventilation, during spontaneous breathing.
실험적: Bag valve mask (BVM) plus PEEP plus Nasal Cannula (NC)
Preoxygenation for 3 minutes using a bag-valve mask (BVM) with positive end-expiratory pressure (PEEP) set at 10 cmH₂O, combined with a nasal cannula delivering supplemental oxygen at 15 L/min for each device, during spontaneous breathing.
장치: Bag-valve mask (BVM) with PEEP + nasal cannula (NC)
Preoxygenation performed using a bag-valve mask equipped with a PEEP valve set at 10 cmH₂O, delivering oxygen at a flow rate of 15 L/min, combined with a nasal cannula delivering supplemental oxygen at 15 L/min. The mask is held with a two-handed technique to ensure an airtight seal, without assisted ventilation, during spontaneous breathing.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Difference in fraction of inspired oxygen (FiO₂) between preoxygenation devices
기간: During each 3-minute preoxygenation session
Fraction of inspired oxygen (FiO₂) delivered during preoxygenation will be continuously measured at the airway opening using a gas analyzer. FiO₂ values will be recorded breath-by-breath during each 3-minute preoxygenation session under all study conditions. The primary outcome is the difference in mean FiO₂ achieved between the different preoxygenation devices (non-rebreather mask, bag-valve mask without PEEP, and bag-valve mask with PEEP), with and without supplemental oxygen via nasal cannula.
During each 3-minute preoxygenation session

2차 결과 측정

결과 측정
측정값 설명
기간
Positive end-expiratory pressure (PEEP) generated during preoxygenation
기간: During each 3-minute preoxygenation session
Airway pressures will be continuously measured to quantify the presence and magnitude of PEEP generated during preoxygenation with bag-valve mask (BVM) with and without a dedicated PEEP valve, with and without nasal cannula oxygen supplementation.
During each 3-minute preoxygenation session
Inspiratory effort required to open the BVM valve
기간: During each 3-minute preoxygenation session
The negative pressure required to open the BVM valve will be measured using airway pressure monitoring, and diaphragm ultrasound parameters (thickening fraction and excursion) will be used as surrogate markers of inspiratory effort.
During each 3-minute preoxygenation session
Ventilation of dependent lung regions
기간: During each 3-minute preoxygenation session
Lung ultrasound will be used to assess regional ventilation of dependent lung areas, with findings quantified using a validated scoring system to compare the effects of preoxygenation with and without PEEP.
During each 3-minute preoxygenation session
Correlation between FiO₂ and tidal volume
기간: During each 3-minute preoxygenation session
The relationship between fraction of inspired oxygen (FiO₂) and tidal volume during preoxygenation will be assessed using continuous, breath-by-breath measurements.
During each 3-minute preoxygenation session
Cardiac output
기간: Baseline and at the end of each 3-minute preoxygenation session
Changes in cardiac output (l/min/m²) will be assessed using echocardiography before and after preoxygenation to evaluate the hemodynamic effects of different devices and PEEP.
Baseline and at the end of each 3-minute preoxygenation session
Changes in right ventricular dimensions
기간: Baseline and at the end of each 3-minute preoxygenation session
Changes in right ventricular dimensions (mm) will be assessed using echocardiography before and after preoxygenation to evaluate the hemodynamic effects of different devices and PEEP.
Baseline and at the end of each 3-minute preoxygenation session
Right ventricular strain
기간: Baseline and at the end of each 3-minute preoxygenation session
Changes in right ventricular strain (%) will be assessed using echocardiography before and after preoxygenation to evaluate the hemodynamic effects of different devices and PEEP.
Baseline and at the end of each 3-minute preoxygenation session

기타 결과 측정

결과 측정
측정값 설명
기간
Airway pressure during breath-holding maneuver
기간: Immediately following the preoxygenation session with bag-valve mask (with or without PEEP)
Airway pressure generated during a brief voluntary breath-holding maneuver will be measured when oxygen is delivered via nasal cannula under a bag-valve mask (with or without PEEP), to assess potential continuous positive airway pressure generation.
Immediately following the preoxygenation session with bag-valve mask (with or without PEEP)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Institute of Mountain Emergency Medicine

수사관

  • 수석 연구원: Simon Rauch, Eurac research, Institute of mountain emergency medicine

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 5월 23일

기본 완료 (추정된)

2026년 6월 30일

연구 완료 (추정된)

2026년 6월 30일

연구 등록 날짜

최초 제출

2026년 4월 26일

QC 기준을 충족하는 최초 제출

2026년 4월 26일

처음 게시됨 (실제)

2026년 5월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 8일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 6일

마지막으로 확인됨

2026년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • PREOXY II

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

전산소화에 대한 임상 시험

Nasal cannula (NC)에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Latvia

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다